Data Registry Management

The Research Data and Information Coordinator administers and coordinates several large data registries and research studies. Services encompass all aspects of projects, from submitting the protocol to the Institutional Review Board (IRB) to securing subject consent and collecting and processing all necessary study data. Current projects underway include the following:

  1. Medtronic Product Surveillance Registry: The Methodist Research Institute participates in the Cardiac Rhythm Disorders arm as well as the Deep Brain Stimulation (DBS) arm (mainly for Parkinson’s Disease and Essential Tremor) of this standard of care registry. Any patient who receives a qualifying Medtronic device is eligible to be followed. Under the cardiac umbrella, these are patients with pacemakers, ICDs, and biventricular devices with implanted leads that bear a qualifying model number. Cardiac patients are eligible for participation for the first 30 days after their implantation procedure. However, DBS patients are given the opportunity to participate in the registry the morning of surgery. A short questionnaire will also be administered at this time. Follow-up questionnaires are worked into the follow-up appointments in clinic. There are no questionnaires for cardiac patients. The purpose of the registry is to continue with evaluating and reporting Medtronic product safety and effectiveness.
  2. National Biological Sample and Data Repository for Pulmonary Arterial Hypertension: This NIH-sponsored registry is for patients who meet the criteria of World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH). To qualify for the registry, a patient’s right heart catheterization measurements need to be within a specific range. Qualifying patients are consented during pulmonology appointments, and those who choose to participate have their blood drawn and analyzed. This is an observational study with multiple objectives: 1) to characterize the demographics and clinical course of patients with WHO group 1 pulmonary arterial hypertension, 2) to evaluate the differences in patient outcomes within WHO group 1 subgroups, 3) to compare outcomes among patients who do and do not meet traditional criteria for establishing the diagnosis of PAH, and 4) to identify clinical predictors of the long- and short-term outcomes.
  3. Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support): This project follows patients who receive FDA-approved ventricular assist devices (VADs). The intent of this national observational study is to raise the standard of care for heart failure patients by following their continued clinical treatment, quality of life measures, and neurocognitive testing results during their hospital stay and routine follow-up visits.

To discuss your data registry project, please contact Colin Terry (317.962.2045).